Kornimate/medical-research-clean huggingface dataset:
physiological abnormalities associated with down syndrome

Conditions: Down Syndrome

Summary: the overall goal of this study is to evaluate biomarkers of oxidative stress, mitochondrial function, and dna methylation (epigenetics) in order to determine the extent to which these biomarkers are related to cognitive, behavioral and adaptive function in down syndrome. the inter-relationship between measurable biomarkers and functional/cognitive abilities will move beyond genetics to provide unprecedented new knowledge and a broader understanding of the underlying pathophysiology and abnormal gene expression induced by trisomy 21.

the investigators preliminary evidence indicates that people with ds have metabolic biomarkers associated with oxidative stress (gsh/gssg) and reduced methylation capacity (sam/sah) as well as abnormal dna methylation (epigenetics). the investigative team hypothesize that these abnormal metabolic processes contribute to abnormalities in behavior and development associated with trisomy 21; this connection has never been investigated. confirming and expanding on the preliminary data would provide new understanding of the biological and functional etiology of the behavioral and developmental delays associated with trisomy 21. further, establishing the underlying relationship between metabolic abnormalities and behavioral/cognitive function over the age spectrum can provide strong support for the design of future treatments of individuals with ds aimed at improving their behavior and development. in addition, these biomarkers may also prove to be predictive biomarkers for the risk of developing asd like behaviors or alzheimer's disease in this population. finally, examining the modulating role of diet in the severity of biological abnormalities will provide new information for lifestyle guidance to improve biomarkers and potentially minimize the medical co-morbidities associated with trisomy 21.

Eligibility criteria:
inclusion criteria: 1. participant or guardian ability to consent/assent and willing to comply with protocol requirements exclusion criteria: 1. trisomy translocation or mosaics. 2. untreated hypothyroidism 3. known history of liver disease, renal disease, hepatitis b or c or hiv 4. recent infection with fever or requiring hospitalization within past 30 days. 5. any medical condition, use of medications, nutrient or herbal supplements that would interfere with the study results as determined by the pi 6. chemotherapy 7. recent surgery (within 2 months) 8. untreated epilepsy 9. any chronic medical/behavioral condition and/or treatments that may interfere with study related outcomes, as determined by pi 10. dementia 11. history of a significant adverse reaction to a prior blood draw 12. any other historical event/information that may, in the opinion of the pi, be a reason to exclude the child from participation.

Keywords: down syndrome typically developing participants children adolescents adults
introvision for migraine and headaches

Conditions: Migraine; Chronic Migraine

Summary: to evaluate the effect of introvision, a mental and emotional self-regulation-technique developed by angelika c. wager, as migraine preventative compared to a waiting list group.

randomized, single-center, waiting-list control group study: introvision as preventative in migraine randomized, single center, waiting-list group control study to evaluate the effect of introvison, a mental and emotional self regulation method to reduce headache days in patients with migraine, migraine and tension type headache and chronic migraine. the number of headache days 3 months after completion of the last session of introvision will be compared with the number of headache days of the waiting list group in the month before the course to learn introvision.

Eligibility criteria:
inclusion criteria: * episodic migraine with at least 5 headache days per month, episodic migraine and tension type headache with at least 5 migraine headache days per month, chronic migraine * stable prophylactic headache medication * stable non-medication headache prophylaxis (sports, relaxation techniques, ...) * informed consent exclusion criteria: * other causes of headache, symptomatic headaches * other primary headaches such as cluster headache, trigeminal neuralgia, idiopathic facial pain, new daily persistent headache * severe depression (more than 13 points in the beck depression inventory fast screen (bdi-fs) * drug - or alcohol abuse * non-compliance, especially significant missing entries in the headache diaries * active psychosis

Keywords: introvision: mental and emotional self-regulation technique mindfulness, perception technique migraine
a blinded randomized clinical study of refluxstop™ compared with nissen fundoplication in the treatment of gerd

Conditions: GERD (Gastroesophageal Reflux Disease)

Summary: this study will evaluate if the refluxstop™ device will treat your acid reflux and improve your symptoms and how it compares to the standard surgical treatment for gerd, the nissen fundoplication.

this study is a post-market prospective, blinded, randomized, multicenter, multi-arm clinical investigation using standard clinical procedures to record data to evaluate the safety and performance of refluxstop™ compared with standard nissen fundoplication for the treatment of subjects suffering from gerd. a randomization will be performed where the subjects will be blinded as to assigned randomization group.

Eligibility criteria:
inclusion criteria: 1. willing and able to provide informed consent and to participate in the clinical investigation; 2. age ≥ 18 years or according to local legal age of adulthood at the location of the test site if older; 3. documented gerd present for ≥ 12 months. typical symptoms are defined as heartburn, which is a burning sensation often presented as a substernal pain; 4. 24-hour ph monitoring proven gerd with ph measurement, off ppi therapy for at least 7 days prior to testing. (total distal esophageal ph must be \< 4 for ≥ 4.5% of time during a 24-hour monitoring); 5. suitable to undergo general anesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator exclusion criteria: 1. \> 8 cm sliding hernia and paraesophageal hernia; no mesh is allowed; 2. manometry verified lack of or moderate or severe weak peristalsis in esophagus with dci \ 15mmhg). hypercontractability defined as dci \>8'000 or pressure \>45 mmhg. thus, excluding from the study the rare diseases achalasia, scleroderma, and nutcracker esophagus, however, including mild esophageal motility disorder patients with mildly weak peristalsis; 3. history of bariatric or anti-reflux surgery; 4. female subjects who are pregnant or nursing; 5. known sensitivity or allergies to silicone materials; 6. intraoperative findings determined by the investigator that may result in unfavorable conduct of the clinical investigation procedure (as outlined in the ifu); 7. subjects that are unable to comply with the clinical investigation requirements (for example due to major psychiatric disorder or are considered otherwise unsuitable for participation in the clinical investigation according to the investigator's judgement);
long-term follow-up (ltfu) of patients treated with genome-edited autologous hematopoietic stem and progenitor cells (hspc)

Conditions: Sickle Cell Disease

Summary: cadpt03a12001 is a prospective, multi-center study that is designed to follow all enrolled patients who have received treatment with otq923 for long-term safety and efficacy.

this study is monitoring patients treated with otq923, an investigational drug product of ex vivo genome-edited autologous hematopoietic stem and progenitor cells (hspcs) that induces fetal hemoglobin (hbf) production, for a total of 15 years following infusion to monitor long-term safety and efficacy.

Eligibility criteria:
inclusion criteria: 1. accepted invitation to join based on prior treatment with gene therapy. 2. patients must provide informed consent prior to their entry into this study. exclusion criteria: 1. completion of less than 1 year of safety follow-up in the treatment protocol (cadpt03a12101)

Keywords: gene therapy genome-edited hematopoietic stem and progenitor cellular therapy sickle cell autologous transplant bcl11a
trends in trans-fatty acid intake between 1980 and 1997

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases

Summary: to examine trends in trans-fatty acid intake by using newly available nutrient data to recalculate 24 dietary recalls from the minnesota heart survey.

background: in recent years concern has arisen about the potential health hazards of trans-fatty acids in the american diet. dietary intake of trans-fatty acids has been linked to unhealthy shifts in serum lipid profiles and to coronary heart disease (chd) in a number of studies. although several studies have estimated intakes of trans-fatty acids in u.s. populations, presently data is lacking regarding trends in intake of trans-fatty acids in the population. furthermore, it is unclear how trends in intake of trans-fatty acids may be related to changes in other dietary and non-dietary chd risk factors and chd mortality. design narrative: the study used newly available nutrient data to recalculate dietary data collected as part of the minnesota heart survey (mhs) to examine trends in intake of trans-fatty acids. the mhs was an ongoing observational epidemiologic study of trends in risk factors and cardiovascular morbidity and mortality among independent cross-sectional probability samples of the minneapolis-st. paul, minnesota, metropolitan area. surveys were conducted in 1980-1982, 1985-1987, 1990-1992 and 1995-1997. diet was among the cvd risk factors measured as part of each survey. in this research, 24-hour dietary recalls collected from mhs participants were recalculated using an updated food and nutrient database that included trans-fatty acid values (16:1, 18:1, 18:2, and total). intake estimates resulting from recalculation were analyzed to examine temporal trends in trans-fatty acid intake between 1980 and 1997, and to examine the relationship of temporal trends in trans-fatty acid intake to temporal changes in other dietary and non-dietary chd risk factors and changes in chd mortality. the mhs data provided a unique opportunity to examine a dietary constituent only recently recognized as a potential risk factor for chd.

Eligibility criteria:
no eligibility criteria
accuracy of intraocular lens power in high myopia

Conditions: High Myopia

Summary: evaluation of the accuracy of iol power in high myopia using different biometry formula \& iol master

high myopia or pathological myopia is associated with elongation of axial length longer than 26 mm or refractive error at least-6 diopter. high myopia is one of the most prevalent refractive condition globally with a higher risk of other eye conditions moreover in high myopic eyes the incidence of cataract is significantly higher than in non myopic eyes and the progression is also faster. calculation of iol in high myopic eyes remains a challenge often leading to unexpected postoperative hyperopia the main potential sources of errors in iol calculation for high myopic eyes include al measurement \& iol constants used \&iol power calculation formula used. investigators suspect that the srk i1 formula is inaccurate for myopic eyes, and that new formulas are needed, taking into account all those factors that make up the dioptric power of an eye. formulas for iol power calculation had past four generations, first generation formulas were theoretical and based on the same fundamental constant with no respect to anterior chamber depth. since then, binkhorst, holladay, hoffer and shammas had refined the existing theoretical formulas where each of them developed his regression formula based on analysis of their previous iol cases . this work was amalgamated in 1980 and yielded the sanders retzlaff kraff i (srki) formula the second generation was designed by combining linear regression analysis and stepwise adjustment for long and short eyes according to anterior chamber depth . the third and fourth generation formulas, started by holladay in 1988, all aimed at better calculation of the iol power in eyes with extreme axial length where another term had appeared which is iol specific anterior chamber depth . the accuracy of third and fourth generation formulas for iol calculation in patients with high axial myopia had not been fully evaluated for that, the need for more studies conducted to evaluate such accuracy is crucial. this study will be conducted to evaluate the accuracy of different formulas used for iol power calculation in patients with high axial myopia undergoing cataract surgery

Eligibility criteria:
inclusion criteria: - 1- patients with clear lense extraction or cataract \& high myope with{ al more than 26 mm. 2-their iolpower is less than 15 diopter or their refraction before operation is more than -6. exclusion criteria: 1. keratoconus patients or those with irregular cornea 2. patients with post operative complications like posterior capsule injury or vitrous loss. 3. patients who had undergone previous intraocular surgery at anterior segment or posterior segment.
post - hospital syndrome: profile of functional status by malnutrition

Conditions: Malnutrition; Sarcopenia

Summary: malnutrition is common problem in hospitalized geriatrics at discharge. malnutrition is a high risk for functional limitations, impaired muscle strength and reduced quality of life.

the majority of geriatric hospitalized patients are at high risk for malnutrition at discharge, which has negative impact on post-hospital outcomes. in a cross-sectional analysis in malnourished, geriatric patients we will evaluate frailty-status and functional status using objective and subjective methods at hospital discharge. moreover, we will investigate the association between nutritional status and frailty, sarcopenia, quality of life and fatigue.

Eligibility criteria:
inclusion criteria: * age ≥ 60 years * informed written consent * existing or risk of malnutrition * normal cognitive status according to mini-mental state examination (mmse ≥ 24 points) * life expectancy of \> 3 months according to treating doctor exclusion criteria: * age \< 60 years * lack of informed written consent * no risk of malnutrition * low cognitive status according to mini-mental state examination (mmse \< 24 points) * life expectancy of \< 3 months according to treating doctor

Keywords: malnutrition disease-related malnutrition frailty sarcopenia hospital discharge geriatrics
pain associated with interproximal enamel reduction in orthodontics: a rct

Conditions: Orthodontic, Interproximal Enamel Reduction

Summary: prospective randomised crossover trial to assess if there is a difference in the level of pain experienced by orthodontic patients undergoing interpromixal enamel reduction at the lower incisor region using either a motor driven reduction device or a hand held device

consenting participants will be randomly allocated to one of the two groups ( motor driven device or hand driven device). a pain questionnaire in the form of a visual analogue scale will be used before the treatment to determine a baseline level of pain and after the chosen treatment to determine the effect or the intervention on pain experience. after a washout period of 6 weeks the participants will crossover to have the opposite intervention carried out. a vas will be filled in before and after the intervention again to determine a baseline pain score and pain score associated with the intervention. the data will be gathered and entered electronically into a statistical package whereby appropriate statistics will be carried out to determine if there is a significant difference in pain experienced between the two methods of enamel reduction. a secondary aim willl be to determine if there is any correlation with pain experienced and age or gender.

Eligibility criteria:
inclusion criteria: * over 18 years * requiring ier in the lower anterior teeth as part of treatment plan * mild crowding in the lower incisor region * centreline discrepancy * discrepancy between the arches mild and thus requiring ipr to correct incisor position * requiring ier for arch coordination no medications willing to participate exclusion criteria: * under 18 years of age not requiring ier * moderate or severe crowding necessitating extraction for relief of crowding * patients with removable appliances as their only mode of treatment patient taking medication not willing to participate
physical activity and ventricular arrhythmias

Conditions: Tachycardia, Ventricular; Defibrillators, Implantable

Summary: the purpose of the study is to determine the effect of aerobic interval training in patients with an implantable cardioverter defibrillator (icd) on physical fitness, quality of life and the amount of serious ventricular arrhythmic events on short and long term.

in this study, participants will be randomly assigned to either take part in the exercise program or serve as control and live as usual. at baseline study visit, study researchers will review medical records to collect various information, including the reason for needing an icd, the type and settings of the icd, medication use and medical history etc. all participants will undergo blood collection, complete a questionnaire to assess quality of life and undergo examination with echocardiography and ecg. the icd will be programmed accordingly to international guidelines regarding icd-therapy and optimal monitoring, before each participant complete an exercise treadmill test to determine vo2 peak. they will wear a holter monitor to record heart activity 48 hours before the test and 24 hours after the test. all participants will then be observed for 2 months before being randomly assigned to either intervention or control. during this observation period, they will wear a fitness activity tracker wristband to evaluate degree of physical activity and a holter monitor to register number of premature ventricular contractions. participants taking part in the interval training group will perform aerobic interval training 4 x 4 minutes intervals, 3 times a week for 12 weeks (week 1-12), whereas participants taking part in the control group will carry on with usual daily life with no lifestyle recommendations. all participants will then undergo a new period of observation (week 13-20) and repeat the tests and examinations performed at baseline and during the observation period prior to intervention/control.

Eligibility criteria:
inclusion criteria: * patients with icd and dilated cardiomyopathy or coronary heart disease as cause for implantation * icd implanted at st olavs hospital, trondheim in case of difficulties with patient inclusion for the study, the criteria might be broadened to include patients with idiopathic ventricular arrhythmia as cause for implantation. exclusion criteria: * inability to accomplish the exercise program due to serious comorbidity or to participate in regular training within the next 3 months due to other reasons * signs of severe cardiac ischemia or persistent ventricular tachycardia during individualized treadmill o2 peak test, which after individual assessment is to be found at risk * comorbidity where endurance training at more than moderate intensity is discouraged * severe cardiac valve disease * planned surgery within the next 3 months * inability to give informed consent

Keywords: exercise training
project on tdcs intervention to enhance advanced social cognitive functions in drug rehabilitation individuals

Conditions: Drug Addiction

Summary: this project aims to explore key brain functional and biochemical indicators associated with impaired advanced social cognition through an integrated approach encompassing unconscious control, conscious control, cognitive flexibility, problem-solving, and social interaction domains. by incorporating multimodal measures spanning physiological, neural, cognitive, psychological, and behavioral dimensions, we will develop a comprehensive intervention protocol combining course-based brain stimulation and cognitive training. the study will employ a multi-timepoint, multi-level assessment framework to track the enhancement of higher cognitive functions and brain functional recovery in individuals undergoing drug rehabilitation.


Eligibility criteria:
inclusion criteria: * age between 30 and 60 years; * fulfilling the diagnostic criteria for severe substance use disorder as specified in the fifth edition of the diagnostic and statistical manual of mental disorders. * a history of heroin use exceeding ten years, with a daily average intake of at least 0.1 grams. * abstinence duration of eight months or less, with a positive result of a urine test before entering the rehabilitation center. * no history of neuromodulation treatments such as tdcs within the past six months. exclusion criteria: * a history of alcohol dependence, neurological disorders, or other complex psychiatric conditions. * the presence of intracranial metallic implants or elevated intracranial pressure. * a history of epilepsy or recent electroencephalogram evidence of epileptiform activity. * the use of implanted electronic devices, such as pacemakers;. * scalp hyperalgesia or a tendency toward bleeding. * severe cardiac conditions.

Keywords: heroin advanced social cognitive function
prognostic value of proadrenomedullin in intra-abdominal sepsis

Conditions: Intraabdominal Infections

Summary: an observational, prospective study whose main objective is to measure the value of pro-adrenomedullin as a prognostic marker and predictor of mortality in patients with intra-abdominal sepsis after damage control surgery.

proadrenomedullin as a severity score and prognostic marker in intra-abdominal sepsis research type: prospective, observational study. duration: october 2016 - october 2017 associated medical centers: la paz university hospital (madrid), la princesa hospital (madrid), hospital del mar (barcelona), hospital clínico de valladolid and hospital clínico de valencia. main goal: to measure the value of pro-adrenomedullin as a prognostic marker and predictor of mortality in patients with intra-abdominal sepsis after damage control surgery. secondary goals: make a comparison with other biomarkers (procalcitonin, lactic acid, crp) and clinical severity scales used in standard critical practice (sapsii, sofa). to establish a correlation between the levels of pro-adrenomedullin, the time of stay in critical care units, days of mechanical ventilation and mortality. variables: a. demographics b. date of admission to hospital and date of admission to critical care unit unit c. clinical data: * associated diseases * saps ii * sofa d. intra-abdominal infection episode data * systemic response: sepsis / septic shock * isolated microorganisms in blood cultures and intra-abdominal fluid * complications related to the infectious process (ards, need for mechanical ventilation, vasopressors, disseminated intravascular coagulation, acute renal failure, renal replacement techniques) e. follow-up * critical unit registration date * date of discharge from hospital * critical unit mortality, in-hospital mortality and 30 days mortality (assessed by telephone contact if the patient had been discharged). f. pro-adrenomedullin levels at admission, 24 and 72 hours. as well as procalcitonin (pct), lactic acid and polymerase chain reaction (pcr) levels.

Eligibility criteria:
inclusion criteria: * all patients consecutively collected, adults over 18, who are admitted to critical care unit with the diagnosis of localized or generalized intraabdominal infection after damage control surgery. exclusion criteria: * pregnant or lactating women. * patients with neutropenia induced by bone marrow transplant or by chemotherapy (\<500 neutrophils / ml).

Keywords: proadrenomedullin sepsis intraabdominal infections prognosis